Supporting Ultra Poor People with Rehabilitation and Therapy among families of children with Cerebral Palsy in rural Bangladesh (SUPPORT CP): Protocol of a randomised controlled trial

Introduction Poverty is a key contributor to delayed diagnosis and limited access to early intervention and rehabilitation for children with cerebral palsy (CP) in rural Bangladesh. 97% of families of children with CP live below the poverty line in Bangladesh. Therefore, in low-and middle-income countries (LMICs), efforts to improve outcomes for children with CP (including health-related quality of life, motor function, communication, and nutritional attainments) should also include measures to improve family economic and social capital. We propose a randomised controlled trial (RCT) to evaluate the effectiveness of an integrated microfinance/livelihood and community-based rehabilitation (IMCBR) program for ultra-poor families of children with CP in rural Bangladesh. Material and methods This will be a cluster RCT comparing three arms: (a) integrated microfinance/livelihood and community-based rehabilitation (IMCBR); (b) community-based rehabilitation (CBR) alone; and (c) care-as-usual (i.e. no intervention). Seven clusters will be recruited within each arm. Each cluster will consist of 10 child-caregiver dyads totalling 21 clusters with 210 dyads. Parents recruited in the IMCBR arm will take part in a microfinance/livelihood program and Parent Training Module (PTM), their children with CP will take part in a Goal Directed Training (GDT) program. The programs will be facilitated by specially trained Community Rehabilitation Officers. The CBR arm includes the same PTM and GDT interventions excluding the microfinance/livelihood program. The care-as-usual arm will be provided with information about early intervention and rehabilitation. The assessors will be blinded to group allocation. The duration of the intervention will be 12 months; outcomes will be measured at baseline, 6 months, 12 months, and 18 months. Conclusion This will be the first RCT of an integrated microfinance/livelihood and CBR program for children with CP in LMIC settings. Evidence from the study could transform approaches to improving wellbeing of children with CP and their ultra-poor families.


Proposed Date of project commencement:
Upon HREC approval

Summary of Project: (Including impact on people with cerebral palsy/other disabilities and academic world)
Bangladesh Cerebral Palsy (CP) Register (BCPR) research findings confirm that poverty is a key contributor to late diagnosis and limited access to early intervention and rehabilitation for children with CP in rural Bangladesh. 97% families of children with CP in the country live below the poverty line. Therefore, in low and middle-income countries (LMICs), efforts to improve outcomes for children with CP (including motor, communication and nutritional attainments) should include measures that improve access to health care services along with family economic/social capital.
We propose a randomized controlled trial (RCT) to evaluate the effectiveness of an integrated microfinance/livelihood and community-based rehabilitation (IMCBR) program for ultra-poor families of children with CP in rural Bangladesh. We predict that IMCBR will facilitate improved access to capital leading to better income and thus increase the family's investment in physical health overall. Moreover, community-based rehabilitation (CBR) will provide an opportunity for sharing ideas, information, and developing important noncognitive skills, such as self-confidence of primary caregivers.
We also expect that the research findings will give crucial evidence regarding the effectiveness of such an integrated program in improving wellbeing of children with CP and Page 2 of 34 Asian Institute of Disability and Development (AIDD) Fostering inclusion through evidence and empowerment their caregivers, health, and economic outcomes of the families. This will eventually guide the implementing partners to scale up the program using in Bangladesh, and in other LMICs.

Study aims and objectives
The aim of this study is to test the effectiveness of an "Integrated Microfinance/livelihood and CBR program" (IMCBR) targeted to children with CP and their parents from ultra-poor families in rural Bangladesh. The program aims to improve the health-related quality of life (HRQoL), motor function, communication and nutritional status of children with CP; mental health, HRQoL and social capital of their parents; and socio-economic status and food security of their families.
Our specific objectives are; 1. To conduct an RCT with three parallel arms comparing (a) IMCBR, (b) CBR alone, and (c) care-as-usual (i.e. no intervention). 2. To measure the effectiveness of IMCBR in improving the HRQoL, motor function, communication, and nutritional status of children with CP from ultra-poor families living in rural Bangladesh. 3. To measure the effectiveness of IMCBR in improving mental health, HRQoL, and social capital of parents of children with CP living in rural Bangladesh. 4. To measure the effectiveness of IMCBR in improving the socio-economic status of ultrapoor families of children with CP living in rural Bangladesh.

Hypothesis
We hypothesize that compared to care-as-usual and CBR alone, the IMCBR program will be more effective in improving HRQoL, motor function, communication, and nutritional outcomes of children with CP from ultra-poor families; and the mental health, HRQoL, and social capital of their primary caregivers; and overall improvement in the socio-economic status of the ultra-poor families of children with CP in rural Bangladesh.

Justification (including literature review and background)
CP is a group of non-progressive neurological disorders caused by damage to the developing brain [1]. The prevalence and severity of CP are considerably higher in LMICs compared with high-income countries (HICs) [2][3][4] and diagnosis is likely to be delayed [3]. Early diagnosis of children with CP and access to evidence-based early interventions such as CBR are key to improving the long-term HRQoL [5], motor function [6], cognitive [7], and other health outcomes in children with CP. However, the majority of evidence in this area represents findings from HICs [8,9]. RCTs testing the effectiveness of CBR programs for children with CP in LMICs are relatively scarce. Moreover, these interventions rarely consider issues pertinent in the lives of children with CP and their families in LMICs such as the impact of living in extreme poverty.
In LMICs, many families of children with CP live in extreme poverty, which contributes to poor health care access, delayed diagnosis, delayed intervention, overall poor health and wellbeing, and long-term reduced effectiveness of rehabilitation therapies [3,[10][11][12][13][14][15]. Our last 16 years of research in rural Bangladesh, which led to the development of Bangladesh CP Register (BCPR -first ongoing population-based CP register in LMICs) [16], confirms that in rural Bangladesh diagnosis of CP is delayed and there is limited or no access to evidence-based rehabilitation programs. The average age at diagnosis of CP in Bangladesh is 5 year compared to 1.5 year in HICs [2,3]. We also found that even when rehabilitation programs were available access to care was negatively impacted by poverty [3,14]. In Bangladesh, 97% of families of children with CP live below the poverty line [3]. These families struggle to meet basic needs and their child's rehabilitation often does not feature high on the agenda. Therefore, an integrated approach combining the physical rehabilitation of children with CP and the economic empowerment of their family is required for tangible long-term improvements.
Microfinance/livelihood support is an effective tool for improving economic, human (including non-cognitive skills), and social capital of disadvantaged people in LMICs particularly vulnerable groups such as women and children [17]. Microfinance/livelihood support programs can improve health by increasing financial access and service utilization. Combining microfinance with health interventions has yielded promising results in the fields of HIV, malaria, and breastfeeding in Africa [18].
In addition, non-experimental and quasi-experimental studies testing the effectiveness of integrated health and economic interventions report significant improvements in reproductive and child health, nutrition, and immunization [19,20]. Non-cognitive skills are considered as important predictors of socio-economic outcomes [21], including the development of small-scale businesses in African context [22,23]. Moreover, interaction between groups in society reduces prejudice and promotes inter-group cooperation [24][25][26].
To be effective, interventions need to be tailored according to the needs of the target population [27]. Influential work by Professor Sir Michael Marmot, Chair of the World Health Organization (WHO) Commission on Social Determinants of Health, and others have demonstrated that socioeconomic factors are important determinants of health [28]. Even in a developed country like the UK, the average life expectancy in poorer areas of Glasgow is about 20 years shorter than that for the rest of the country [29]. This gap can be explained as a direct result of poverty and related social disadvantage. Tangible improvements in overall health status of people living in poverty can only be achieved by focusing on improving both health and economic/social capital. However, to our knowledge, no studies have examined the effectiveness of an integrated health and economic approach for children with CP and their families in LMICs.

Statement of Outcomes & Benefits
We believe that this will be the first RCT of an integrated microfinance/livelihood and CBR program for children with CP in LMIC settings. Evidence from the study could transform approaches to improving wellbeing of children with CP and their families living in extreme poverty. The study has been informed by our work on population-based surveillance (i.e. BCPR) and CBR in the local areas, indicating the need for interventions to focus on both health and economic improvement. We will be able to compare the effectiveness of CBR with a new integrated intervention as well as comparing both with standard care practiced in the locality. These data will be scientifically valuable for large scale sustainable program implementation.
On the other hand, people with disabilities and their families are often excluded from social and economic activities in LMICs. About 97% of the families of children with CP in rural Bangladesh live in extreme poverty [3]; only 31% of ultra-poor families of people with disabilities receive government benefits (in form of social protection) [30]. If the proposed integrated program is proved to be scientifically effective in improving the overall quality of life of children with CP and their caregivers, health, and economic outcomes of the families, the implementing NGO partner plans to scale up the program using existing connections with NGOs and microfinance organizations in Bangladesh, and in other LMICs where CSF Global is research active (e.g., Nepal, Indonesia, and Ghana). Method Design Overview of the study design This will be a cluster randomized controlled trial comprising three arms. The unit of randomization will be a cluster. Clusters randomized to intervention arms of the trial (i.e. IMCBR and CBR arms) will receive interventions following the protocol outlined in later sections. The interventions will be provided to dyads consisting of children with CP and their primary caregivers. Whereas, clusters randomized to care-as-usual arm of the trial will not receive any active intervention. (Annexure-2)

Participant Inclusion/ Exclusion Criteria
Inclusion/exclusion criteria Participants will be considered eligible for participation based on the following criteria: 1. Children with CP aged ≤5 years, classified as from an ultra-poor family (i.e. per day per capita income <1.90 USD; [31]) and registered in the BCPR. The BCPR registers children with CP following the case definition adopted from the Surveillance of CP in Europe (SCPE) and the Australian CP Register (ACPR) [3]. 2. Primary caregiver (e.g. parent, sibling, grandparent of the child with CP) 3. Primary caregiver has the capacity to give informed consent and is willing to take part in the study including microfinance/livelihood arm along with their child with CP.
Participants will be considered ineligible for participation based on the following criteria: 1. Currently in receipt of microfinance/livelihood support from another source. 2. Currently participating in any other clinical trial or intervention program.

Sample size calculation
The sample size for this cluster RCT has been computed based on methods described in Donner et al. [32]. We will recruit seven clusters in each arm, and each cluster will consist of 10 CP children with CP-primary caregivers dyads totaling 21 clusters of 210 dyads. Based on our pilot data and existing literature we predict 35% improvement of HRQoL in the IMCBR group, 20% improvement in the CBR alone group, and 5% improvement in the care-as-usual group. With a sample size of 210 dyads, this study will have 80% statistical power to detect these effects (two-sided α-value=0.05) [9]. Power calculation takes into account up to 20% sample attrition by the end of the trial. A homogeneous study population will allow us to balance randomization considering intra-cluster correlation of 0.5 and coefficient of variation in cluster size of 0.5.

Cluster formation and randomization
The study will include 21 clusters randomized to three arms (7 clusters each) and allocated by a 1:1:1 ratio. Each cluster will come from a 'Mouza', the smallest public administrative unit in Bangladesh comprising of approximately five villages (~8,250 people) and will include 10 CP child-primary caregiver dyads. In order to minimize 'contamination' of the intervention types, clusters will be separated from each other by buffering areas comprising villages not taking part in the study. Cluster margins will be configured so that they align with natural divisions that separate residents in the community (e.g., rivers). The randomization process will be executed following the standard process.

Recruitment
The study will utilize the Bangladesh CP Register (BCPR) as a sampling frame for participant recruitment. The BCPR is an ongoing surveillance of children with CP commenced in 2015 [3], and currently being operated in four districts of Bangladesh. Between 2015 and 2019, 1125 children with CP have been registered into the BCPR from Shahjadpur (i.e. the study site). As part of this RCT, dyads of children with CP and their primary caregivers who meet the inclusion criteria will be recruited and assigned to different arms of the study. The BCPR findings show that 34.2% of the children registered are aged <5 years and 97% of the families are ultra-poor (i.e. per day per capita income <1.90 USD) [3]. Considering the number of registrants from Shahjadpur (i.e.~1125), there are ~373 children eligible to participate in the study. Therefore, recruitment of 210 children and their primary caregiver in the trial (<60% of the available pool) is feasible. Sociodemographic, economic, and health data of these children and their families are already recorded in the BCPR allowing quick identification and recruitment. All families enrolled in the BCPR have also been mapped using Geographic Information System (GIS). (Annexure-3)

Intervention Arm A-Integrated Microfinance/livelihood and Community-Based Rehabilitation (IMCBR)
Participants randomized to the IMCBR arm will be supported to create microfinance/livelihood groups (10 participant-pairs per group). The groups will be formed voluntarily along geographical boundaries to facilitate participation, retention, and meeting logistics. Each cluster will meet weekly to discuss microfinance/livelihood activities (e.g. weekly credit collection and troubleshooting) (90 minutes) and for CBR with children with CP comprising early intervention and primary caregiver's education (90 minutes).

A.1 Microfinance/livelihood program details
Group meetings will be organized with members of each cluster to discuss (i) details of the program, (ii) potential benefits and challenges of participation in the program, and (iii) motivations for participation. Participants of each cluster can then apply for a loan/livelihood Page 5 of 34 Asian Institute of Disability and Development (AIDD) Fostering inclusion through evidence and empowerment support; a minimum 10% deposit of the requested loan/livelihood support amount in the form of savings is required and is admissible immediately after cluster formation. Once the application is completed, loan approval and disbursement of the loan will occur approximately within one week. Amount, return cycle of loan and investment areas: Each of the ultra-poor families will receive a loan/livelihood support amounting/equivalent to ~100-300AUD at 12% flat interest rate. The return cycle will be one year with a weekly repayment schedule. Common investment areas for the ultra-poor loan will be for goat or cattle rearing, seeds for agriculture, home-based weaving, and handicraft business [33]. Using a structured tool (Annexure-4) a comprehensive needs assessment will be conducted to guide the decision of livelihood support to be provided.

A.2 CBR
There will be two major components of the CBR program, which will occur during cluster meetings following the microfinance/livelihood portion. a. Goal Directed Training (GDT): Community-based GDT focused on motor learning will be conducted with children with CP and their primary caregivers. GDT is an activity-based approach to therapy where meaningful, client-selected (i.e. caregivers of children with CP) goals are used to provide opportunities for problem-solving and to indirectly drive the movements required to successfully meet task demands [34]. Evidence from a metaanalysis shows that GDT based interventions are highly effective and should be the gold standard treatment for CP [35]. In this study, GDT will be delivered by child's primary caregiver (participating parent).

b. Parents Training Module (PTM):
Primary caregivers will participate in PTM to learn basic therapeutically correct skills for the day-to-day care and support of their child with CP embedded in the principles of GDT. This study will follow the PTM 'Getting to know cerebral palsy' which includes 10 modules and covers topics; introduction to CP, evaluating your child, positioning and carrying, communication, everyday activities, feeding your child, play, disability in your local community, running your own parent support group, and assistive devices and resources [36].
Specially trained Community Rehabilitation Officers (CRO's) will facilitate each of the cluster meetings (both microfinance/livelihood and CBR activities). The CROs will facilitate microfinance/livelihood discussions and lead the GDT and PTM sessions with the aim to upskill primary caregivers so that they can continue to deliver GDT independently at home. Prior to implementation of the RCT, CROs will take part in a 5-day training by Research Physiotherapist. The CRO training will cover the following areas; (i) socio-cultural considerations in working with primary caregivers of children with CP, (ii) introduction to microfinance/livelihood support program management, (iii) developmental milestones and development in children with CP, (iv) therapeutic principles, (v) GDT, (vi) activity focused therapies, (vii) basic speech development strategies, (viii) contraindications of therapies, (ix) research ethics, and (x) child rights.

Arm B-CBR alone
Participants from clusters randomized to this arm will attend a weekly rehabilitation session at a local focal point (preferably one of the group members' home). Each session will last for 90 minutes and will be identical to the CBR component of IMCBR (discussed above); however, the microfinance/livelihood component will not be provided.

Arm C-Care-as-usual (i.e. no intervention)
This group will not receive any active intervention. Once children with CP are identified and randomized into clusters, the 'care-as-usual' participants will be provided with basic education on early intervention and rehabilitation and will be encouraged to access healthcare via usual routes, which typically include treatment in government hospitals. The proposed intervention schedules for all three arms have been summarized in Annexure-5.

Concurrent interventions
Children with CP from all three study arms will be able to continue accessing need-based medical and therapy support from other sources as per their family's preferences. Frequency and duration of access to local medical/therapy services will be recorded during follow-up assessments and included in analysis.

Outcome measures
The following outcomes will be measured at baseline, at 6 months, 12 months, and 18 months. The tools that will be used to measure outcomes have been outlined in Annexure-6.

Data management and analysis
Data will be collected using paper-based forms. Research data will be anonymized and stored securely and separately for participant identifiable information. This will include monitoring secure data transfer from field to the central office, data entry and quality control of completed forms, querying of missing or invalid data, and archiving of physical forms. Data will be collected using validated questionnaires. Data will be entered into PCs using Microsoft Access or SQL Server as the relational database engine. Any error identified during data entry or in data cleaning will be logged for field supervisor assessment and will be resolved after proper field verification. The physical data will be stored for 7 years in a locked cabinet at head office of CSF Global based in Bangladesh as per national and international guidelines.
Intention-to-treat analysis will compare improvements in primary and other outcomes between groups controlling for baseline measures. Descriptive statistics (frequencies, means and 95% confidence intervals) will be used to describe the sample at baseline and post-intervention. Hypothesis testing will be done using appropriate statistical procedures (e.g., Chi-square test, Fisher's exact test, paired t test, ANOVA) based on the distribution nature and type of data. To account for the intra-cluster correlation in calculating 95% CI and p-value, we will use Sandwich estimate of standard error. Baseline characteristics will also be compared and adjusted using appropriate regression models. All analyses will be conducted using STATA 15, with the significance level set at p<0.05. Data visualization will be done using R studio/GraphPad Prism 7.

Dissemination of Results & Recommendation
The study findings will be shared with local and national Micro Finance Institutions and nongovernmental organizations. We also aim to publish the trial findings in peer-reviewed journals and present at national and international conferences/workshops. Findings from this study, including key learnings, will be shared with stakeholders including rehabilitation practitioners working with children with CP in Bangladesh and other LMICs. The findings will also be shared with the participating parents of children with CP in the proposed study sites.

Allocation of Resources (AIDD Staff Only) Staff Time
Other -give details This research proposal may be submitted to an external reviewer with appropriate expertise in the topic.
Please indicate if you have any objection to this process.

Annexure-3: Geographic Information System (GIS) map of the study area and eligible clusters
Cluster of eligible participants drawn from the BCPR cohort with geographical boundary and position in the study area.  Milk cows/bulls iii.
Other farm animals 2.7 Does your household own any homestead? IF 'NO' PROBE: Does your household own homestead in any other places? Yes=1, No=2  If 'Yes', How often did this happen? 1= Rarely (≤2 days in the last month) 2= Sometimes (3-10 days in last month) 3= Often (>10 days in last month) 4.1 In the past four weeks, did you worry that your household would not have enough food? 4.2 In the past four weeks, were you or any household member not able to eat the kinds of foods you preferred because of a lack of resources? 4.3 In the past four weeks, did you or any household member have to eat a limited variety of foods due to a lack of resources? 4.4 In the past four weeks, did you or any household member have to eat some foods that you really did not want to eat because of a lack of resources to obtain other types of food? 4.5 In the past four weeks, did you or any household member have to eat a smaller meal than you felt you needed because there was not enough food? 4.6 In the past four weeks, did you or any other household member have to eat fewer meals in a day because there was not enough food? 4.7 In the past four weeks, was there ever no food to eat of any kind in your household because of lack of resources to get food? 4.8 In the past four weeks, did you or any household member go to sleep at night hungry because there was not enough food? 4.9 In the past four weeks, did you or any household member go a whole day and night without eating anything because there was not enough food? Fostering inclusion through evidence and empowerment

Hypothesis
We hypothesize that compared to care-as-usual and CBR alone, the IMCBR program will be more effective in improving HRQoL, motor function, communication, and nutritional outcomes of children with CP from ultra-poor families; and the mental health, HRQoL, and social capital of their primary caregivers; and overall improvement in socio-economic status of the ultra-poor families of children with CP in rural Bangladesh.

Significance
To the best of our knowledge, this will be the first RCT of an integrated microfinance/livelihood and CBR program for children with CP in LMIC settings. Evidence from the study could transform approaches to improving the wellbeing of children with CP and their families living in extreme poverty. The study has been informed by the findings of a population-based surveillance (i.e. Bangladesh CP Register) and CBR in the local areas, indicating the need for interventions to focus on both the health and economic improvement. This study will be able to compare the effectiveness of CBR with a new integrated intervention as well as comparing both with standard care practiced in the locality. We propose a six months follow-up after completion of the intervention to test the longer-term impact of the intervention. These data will be scientifically valuable for large scale sustainable program implementation.
On the other hand, people with disabilities and their families are often excluded from social and economic activities in low-and middle-income countries (LMICs). About 97% of the families of children with CP in rural Bangladesh live in extreme poverty [1]; only 31% of ultrapoor families of people with disabilities receive government benefits (in form of social protection) [2]. If the proposed integrated program is proved to be scientifically effective in improving the wellbeing of children with CP and their caregivers, health, and economic outcomes of the families, the implementing partner plans to scale up the program using existing connections with NGOs and microfinance organizations in Bangladesh, and in other LMICs where CSF Global is research active (e.g. Nepal, Indonesia and Ghana).

Give a succinct but comprehensive statement of the scientific background to the project and project plan
Bangladesh CP Register research findings confirm that poverty is a key contributor to late diagnosis and limited access to early intervention and rehabilitation for children with CP in rural Bangladesh [1]. 97% families of children with CP in the country live below the poverty line. Therefore, in LMICs, efforts to improve outcomes for children with CP (including quality of life, motor, cognitive and nutritional attainments) should also include measures to improve family economic/social capital. We propose a randomized controlled trial to evaluate the effectiveness of an integrated microfinance/livelihood and community-based rehabilitation (IMCBR) program for ultra-poor families of children with CP in rural Bangladesh. We hypothesize that IMCBR will facilitate improved access to capital leading to better income and thus increase the family's investment in physical health overall. Moreover, CBR will provide an opportunity for sharing ideas, information, and developing important noncognitive skills, such as self-confidence of primary caregivers.

Briefly describe all methodology to be used with participants
This will be a cluster RCT comparing three arms: (a) IMCBR; (b) CBR alone; and (c) careas-usual (i.e. no intervention).
Seven clusters will be recruited within each arm. Each cluster will consist of 10 childcaregiver dyads totaling 21 clusters with 210 dyads.
Parents recruited in the IMCBR arm will take part in a microfinance/livelihood program and CP Parent Training Module (PTM), their child with CP will take part in a Goal Directed Training (GDT) program on a weekly basis. The CBR arm includes the same GDT and PTM Page 3 of 10 Asian Institute of Disability and Development (AIDD) Fostering inclusion through evidence and empowerment interventions excluding the microfinance/livelihood program. The programs will be facilitated by specially trained Community Rehabilitation Officers (CROs). Whereas, the care-as-usual arm will be provided with information about early intervention and rehabilitation.
The duration of the interventions will be 12 months and outcomes will be measured at baseline, and at 6, 12, and 18 months using a standard pre-tested questionnaire. The assessors will be blinded to group allocation.
Data management and analysis will be conducted using STATA.
Give a statement of the possible dangers or ill effects of these procedures and the precautions to be taken to prevent or minimize them It is extremely unlikely that GDT as part of CBR will result in any adverse outcomes. However, to minimize any potential risks from rehabilitative services the CROs will be trained thoroughly on basic therapeutic skills. In addition to that, they will also be taught how to assess adverse effects and when to stop providing rehabilitation services. Furthermore, one experienced Research Physiotherapist will be responsible for supervising CROs and monitor their service delivery. Each participant will also be assessed thoroughly by a trained clinician and physiotherapist at the first stage of the study and if there is any contraindication for active therapy, the participant will not be recruited into the study.

Give a statement on the demands, inconvenience or discomfort to the participants
We will use adequate safeguards (as described above) to minimize any associated physical risks. There will be no potential risk (related to privacy) to the participants from this study. Assessment and interview for the study will be conducted in communities close to the study participants. It is possible that the attendance to the weekly meeting may result in a loss of work time. Participation in the study may require 180 minutes maximum per week and participants will be registered in the study only if they agree to commit this time voluntarily. It is expected that parents will participate in the weekly meetings realizing that this will be beneficial for their child. However, no monetary benefits will be given to compensate for the given time. The consent form will contain both of these information. Families will be provided with information about the study. The health professionals will explain in detail the purpose of the study. If they are illiterate, the information sheet will be read out to the family members/caregivers in the local language (Bengali) and written consent will be obtained from the participants or caregivers.

Give the number, type and age range of all the participants, including controls
Participants will be considered eligible for participation based on the following criteria: 1. Children with CP aged ≤5 years, classified as from an ultra-poor family (i.e. per day per capita income <1.90 USD; [3]) and registered in the BCPR. The BCPR registers children with CP following the case definition of CP used by Surveillance of CP in Europe (SCPE) and the Australian CP Register (ACPR) [1]. 2. Primary caregiver (e.g. parent, sibling, grandparent of the child with CP) 3. Primary caregiver has the capacity to give informed consent and is willing to take part in the study including microfinance/livelihood arm along with their child with CP.

Sample size calculation
The sample size for this cluster RCT has been computed based on methods described in Donner et al. [4]. We will recruit seven clusters in each arm, and each cluster will consist of 10 CP children with CP-primary caregivers dyads totaling 21 clusters of 210 dyads. Based on our pilot data and existing literature we predict 35% improvement of HRQoL in the IMCBR group, 20% improvement in the CBR alone group, and 5% improvement in the care-as-usual group. With a sample size of 210 dyads, this study will have 80% statistical power to detect these effects (two-sided α-value=0.05) [5]. Power calculation takes into account up to 20% sample attrition by the end of the trial. A homogeneous study population will allow us to balance randomization considering intra-cluster correlation of 0.5 and coefficient of variation in cluster size of 0.5.

Sources and means of recruitment
The study will utilize the BCPR as a sampling frame for participant recruitment. The BCPR is an ongoing surveillance of children with CP commenced in 2015 [1], and currently being operated in four districts of Bangladesh. Between 2015 and 2019, 1125 children with CP have been registered into the BCPR from Shahjadpur (i.e. the study site). As part of this RCT, dyads of children with CP and their primary caregivers who meet the inclusion criteria will be recruited and assigned to different arms of the study.